Fulvestrant in postmenopausal women with metastatic breast cancer progressing on prior endocrine therapy-updated results from an expanded access programme

Petruželka, Luboš; Konopasek,; Pribylova, O.; Zimovjanová, Martina

doi:10.1016/s1359-6349(06)80443-x

Cited by 7 publications

(6 citation statements)

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“…In both sets of data, fulvestrant displayed activity in patients with visceral metastases and in HER2-positive disease. Activity in patients with visceral metastases has also been reported in smaller cohorts of patients receiving fulvestrant via a CUP Cardoso et al [10], Petruzelka et al [11]. Such efficacy has also been reported in Phase III trials of fulvestrant versus anastrozole Mauriac et al [12].…”

Section: Discussionmentioning

confidence: 80%

Fulvestrant (Faslodex™) in advanced breast cancer: clinical experience from a Belgian cooperative study

Neven

Paridaens

Pelgrims

et al. 2007

Breast Cancer Res Treat

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Fulvestrant (Faslodex) is a new estrogen receptor (ER) antagonist with no agonist effects that is licensed for the treatment of postmenopausal women with hormone-sensitive advanced breast cancer (ABC) who have progressed/recurred on prior antiestrogen therapy. The Faslodex Compassionate Use Program (CUP) provides expanded access to fulvestrant in countries where it is not yet available for patients who are not eligible to enter clinical trials. This analysis pools data from 402 patients who received fulvestrant as part of the CUP in Belgium, predominantly as 3rd- to 5th-line endocrine therapy for ABC. Two patients experienced partial responses and 118 experienced stable disease lasting>or=6 months, resulting in an overall clinical benefit rate of 29.9%. Fulvestrant was active in patients with multiple sites of metastases, visceral metastases, human epidermal growth factor receptor 2-positive disease and after heavy endocrine pre-treatment. Fulvestrant was well tolerated, with only six patients (1.5%) discontinuing treatment following adverse events. These data support the findings of previous CUP analyses and Phase II and III trials, suggesting that fulvestrant is a valuable addition to the treatment sequence for postmenopausal women with ABC who have progressed/recurred on prior endocrine therapy.

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Section: Discussionmentioning

confidence: 80%

Fulvestrant (Faslodex™) in advanced breast cancer: clinical experience from a Belgian cooperative study

Neven

Paridaens

Pelgrims

et al. 2007

Breast Cancer Res Treat

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“…Similarly, in another phase II trial of 77 patients with advanced breast cancer who had progressed on prior AI therapy (21 had also received tamoxifen), 32.5% gained CB with fulvestrant (Ingle et al 2004(Ingle et al , 2006. Additionally, in the compassionate-use programme, CB was achieved in patients who received fulvestrant after progression on prior endocrine therapies, including both AIs and SERMs (Petruzelka et al 2004, Steger et al 2005. Importantly, tumour sensitivity to subsequent endocrine therapies appears to be maintained after fulvestrant treatment , Robertson et al 2005.…”

Section: Future Directionsmentioning

confidence: 95%

“…For patients who were not eligible to receive fulvestrant as part of a clinical trial and in countries where fulvestrant was not yet approved, fulvestrant was available as part of a compassionateuse programme (Franco et al 2004, Petruzelka et al 2004, Steger et al 2005.…”

Section: Experience From a Compassionate-use Programmementioning

confidence: 99%

“…A further report has described an additional cohort of 64 pretreated patients (78% had received fulvestrant as second-or third-line endocrine therapy and 64% had received prior chemotherapy) (Petruzelka et al 2004). In total, 39 patients (61%) experienced CB (CR C PR C SD R24 weeks), including five patients (8%) with an OR.…”

Section: Experience From a Compassionate-use Programmementioning

confidence: 99%

“…A durable and ongoing OR was observed in 3/44 patients (R18.5 to R21.2 months in duration), and 18/44 patients experienced ongoing SD of R24 weeks (R6.5 to R20.3 months). Of the five patients with an OR, three had ER-positive and PgR-positive tumours and all had received prior non-steroidal AI treatment (Petruzelka et al 2004).…”

Section: Experience From a Compassionate-use Programmementioning

confidence: 99%

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Pure oestrogen antagonists for the treatment of advanced breast cancer

Howell¹

2006

Endocr Relat Cancer

107

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For more than 30 years, tamoxifen has been the drug of choice in treating patients with oestrogen receptor (ER)-positive breast tumours. However, research has endeavoured to develop agents that match and improve the clinical efficacy of tamoxifen, but lack its partial agonist effects. The first 'pure' oestrogen antagonist was developed in 1987; from this, an even more potent derivative was developed for clinical use, known as fulvestrant (ICI 182,780, 'Faslodex'). Mechanistic studies have shown that fulvestrant possesses high ER-binding affinity and has multiple effects on ER signalling: it blocks dimerisation and nuclear localisation of the ER, reduces cellular levels of ER and blocks ER-mediated gene transcription. Unlike anti-oestrogens chemically related to tamoxifen, fulvestrant also helps circumvent resistance to tamoxifen. There are extensive data to support the lack of partial agonist effects of fulvestrant and, importantly, its lack of cross-resistance with tamoxifen. In phase III studies in patients with locally advanced or metastatic breast cancer, fulvestrant was at least as effective as anastrozole in patients with tamoxifen-resistant tumours, was effective in the first-line setting and was also well tolerated. These data are supported by experience from the compassionate use of fulvestrant in more heavily pretreated patients. Further studies are now underway to determine the best strategy for sequencing oestrogen endocrine therapies and to optimise dosing regimens of fulvestrant. At present, and for the foreseeable future, fulvestrant is the only oestrogen antagonist with no agonistic effects licensed for the treatment of advanced breast cancer in postmenopausal women. Other similar oestrogen antagonists are undergoing research and development, with a few currently being evaluated in phase II trials.

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Case studies of fulvestrant (‘Faslodex’) in postmenopausal women with advanced breast cancer

Abram¹,

Maass

Rea³

et al. 2005

Cancer Treatment Reviews

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Fulvestrant in postmenopausal women with metastatic breast cancer progressing on prior endocrine therapy-updated results from an expanded access programme

Cited by 7 publications

References 0 publications

Fulvestrant (Faslodex™) in advanced breast cancer: clinical experience from a Belgian cooperative study

Fulvestrant (Faslodex™) in advanced breast cancer: clinical experience from a Belgian cooperative study

Pure oestrogen antagonists for the treatment of advanced breast cancer

Case studies of fulvestrant (‘Faslodex’) in postmenopausal women with advanced breast cancer

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